On June 29 2011 the European Chemicals Agency (ECHA) issued a helpful shortened version of its guidance documents on the requirements for substances in articles, which are set out in the EU Regulation Concerning the Registration, Evaluation and Authorisation of Chemicals (REACH) (1907/2006). The shortened guidance provides a number of clarifications regarding the obligations on companies which place articles on the European market.
The REACH regulation, adopted in 2006, has quickly become one of the most voluminous instruments of EU legislation in existence. The need to provide guidance to companies in order for them to be able to fulfil their REACH obligations remains significant. The recent updated and shortened guidance document aims to address this need in relation to some important REACH provisions in a practical manner.
REACH applies to chemical substances, mixtures of substances and articles that contain chemicals. Any object whose function is determined more by its shape, surface or design than by its chemical composition is considered to be an 'article' for the purposes of REACH. Everyday consumer goods, ranging from toys, clothing and electronic equipment to passenger cars, are considered to be articles.
Most of the requirements that the regulation sets out are intended for producers and importers of goods which are active within the European Union. However, the ECHA stresses the importance of the obligation to communicate information on substances in articles: an obligation which falls not only on producers and importers of articles within the European Union, but – effectively – also on the wider category of 'suppliers', regardless of where in the world they are established.
Regarding this obligation to communicate, the ECHA provides some clarification. In essence, the requirement is as follows: whenever more than 0.1% of an article consists of products which can seriously affect human health or the environment, the supplier is obliged to provide recipients down the supply chain with relevant safety information. The same obligation applies where a consumer makes a request for such information.
This obligation raises a number of questions. First, when does a product have the potential to seriously affect human health or the environment? The ECHA has drawn up a Candidate List of Substances of Very High Concern for Authorisation; all substances on this list (which is growing) are deemed dangerous and are thus labelled as substances of very high concern (SVHCs). If more than 0.1% of the article consists of a substance mentioned in the candidate list, then the communication obligation applies.
Second, how is the 0.1% threshold calculated? Here, useful clarifications are provided in the guidance document. The obligation to communicate applies, potentially, for all articles, regardless of quantity (eg, even if less than one tonne of the article is imported per year). Furthermore, the packaging of an article is treated as a separate article from the contents of the package. Therefore, the obligation to communicate information on SVHCs applies to the packaging as well.
Third, to whom must the information be provided, and when? All suppliers must automatically inform recipients (downstream actors in the supply chain) of SVHCs in their products. All industrial or professional users and distributors are considered recipients; consumers are not. On the other hand, suppliers must inform consumers at their request. Suppliers must answer consumer enquiries within 45 days, free of charge. The obligation to communicate to consumers is reportedly being tested by non-governmental organisations and environmentalists, with requests being sent out to major retailers all over the European Union to see whether they comply with this obligation.
Fourth, what is meant by 'relevant safety information'? In other words, what kind of information must the supplier provide? Here, the guidance considers relevant safety information as "the information necessary to allow safe use of the article". Suggestions are provided:
"the supplier has to consider how the article is used, which exposures and risks could arise and which information, in particular, or risk management, is required for the user of the article to ensure safe handling".
The service life of the product should be considered, as well as instructions for its disposal, specific storage or transport. In any case, as a minimum, the name of the substance in question must be communicated.
Fifth, how must this information be provided? The REACH regulation does not specify a format. The document mentions that companies must choose a format that will ensure that the information is readily available to the recipient of the article or the consumer.
Since communication has become a legal requirement for companies active within the European Union, the need for these companies to have access to reliable information as to the composition of articles imported has increased significantly. Therefore, the ECHA stresses the importance of supply chain communication.
Retailers of, for example, consumer goods rely on their (upstream) suppliers for correct information. Companies responsible for the production of many consumer goods that are brought into circulation on the EU market thus assume an important responsibility. In its guidance the ECHA explicitly proposes that companies at the bottom of the supply chain contact producers, formulators and manufacturers directly and proactively. The ECHA proposes that suppliers introduce certificates which guarantee to their buyers that certain substances are not used in the manufacture of products or remain below certain concentrations. A second proposal is to supply contracts excluding or limiting the presence of certain substances. Both proposals are novel to this guidance.
Producers and importers of articles may also have to comply with the obligation to notify the substances in articles. This involves the submission of specific information on a substance and its uses in articles, as well as the use of the article, to the ECHA. Notification of a substance in articles is required by an EU producer or importer where:
- the substance is an SVHC on the candidate list;
- it is present in the articles at a concentration of above 0.1%; and
- the total amount of the substance present in all articles produced and/or imported, which contain more than 0.1% of the substance, exceeds 1 tonne per year for the producer/importer.
However, certain exemptions apply. For more details, companies should peruse the guidance documents on the ECHA website.(1)
For further information on this topic please contact Reshad Forbes at Van Bael & Bellis by telephone (+32 2 647 73 50), fax (+32 2 640 64 99) or email ([email protected]).
Endnotes
(1) The guidance document on substances in articles can be accessed at http://guidance.echa.europa.eu/docs/guidance_document/nutshell_guidance_articles2_en.pdf. More extensive guidance on the same topic can be accessed at http://guidance.echa.europa.eu/docs/guidance_document/articles_en.pdf.